BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6448740 · Received March 31, 2017

    Report

    Report Number
    2029214-2017-00323
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    January 6, 2017
    Report Date
    March 3, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MATTHEW B. POTTS, MD, MAKSIM SHAPIRO, MD, DANIEL W. ZUMOFEN, MD, EYTAN RAZ, MD, EREZ NOSSEK, MD, KEITH G. DESOUSA, MD, TIBOR BECSKE, MD, HOWARD A. RIINA, MD, AND PETER K. NELSON, MD. PARENT VESSEL OCCLUSION AFTER PIPELINE EMBOLIZATION OF CEREBRAL ANEURYSMS OF THE ANTERIOR CIRCULATION. J NEUROSURG JANUARY 6, 2017 THE DEVICE WAS NOT RETURNED AS IT WAS IMPLANTED IN THE PATIENT; THEREFORE, PRODUCT ANALYSIS OF THE PIPELINE DEVICES WAS NOT ABLE TO BE PERFORMED. THE MODEL AND LOT NUMBERS OF THE PIPELINE EMBOLIZATION DEVICES IMPLANTED WERE NOT REPORTED IN THE ARTICLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE MAIN AUTHOR OF THIS ARTICLE, HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED. SHOULD THE REQUESTED INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE AUTHORS PERFORMED A RETROSPECTIVE REVIEW OF ALL ANTERIOR CIRCULATION ANEURYSMS CONSECUTIVELY TREATED AT A SINGLE INSTITUTION WITH THE PED THROUGH 2014, IDENTIFYING THOSE WITH PVO ON FOLLOW-UP IMAGING. THE CAUSES OF PVO IN THIS SERIES WERE NOT CONFIDENTLY IDENTIFIED BY THE AUTHORS. THE AUTHORS NOTE THAT THE CASES OF DELAYED PVO IN THE LITERATURE HAVE BEEN REPORTED TO OCCUR SOON AFTER DISCONTINUATION OF CLOPIDOGREL, EITHER AS PRESCRIBED BY THE TREATING PHYSICIANS BASED ON MEDICAL NECESSITY OR FOLLOW-UP IMAGING 6,9,13 OR WHEN SELF-DISCONTINUED BY PATIENT. WITH REGARDS TO IN-STENT STENOSIS, THE AUTHORS NOTED THAT IT IS NOT CLEAR HOW SOON AFTER PIPELINE EMBOLIZATION THE IN-STENT STENOSIS OCCURRED SINCE THIS OCCLUSIONS WERE DISCOVERED ON THE FIRST FOLLOW-UP ANGIOGRAM AFTER EMBOLIZATION. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. AFTER REVIEWING THE IFU, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE COMPLAINT IS RELATED TO THE PATIENT CONDITION. REFERENCE MDRS 2029214-2017-00323, 2029214-2017-00324, 2029214-2017-00325, 2029214-2017-00326, 2029214-2017-00327, 2029214-2017-00328 FOR THIS SUBJECT. OTHER MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00295, 2029214-2017-00296, 2029214-2017-00297, 2029214-2017-00298, 2029214-2017 -00299 2029214-2017-00300, 2029214-2017-00301, 2029214-2017-00302, 2029214-2017-00303, 2029214-2017-00304, 2029214-2017-00305, 2029214-2017 -00306, 2029214-2017-00307, 2029214-2017-00308, 2029214-2017-00309, 2029214-2017-00310, 2029214-2017-00311, 2029214-2017-00312, 2029214-2017-00313, 2029214-2017-00314, 2029214-2017-00315, 2029214-2017 -00316, 2029214-2017-00317, 2029214-2017-00318, 2029214-2017-00319, 2029214-2017-00320, 2029214-2017-00321, 2029214-2017-00322, 2029214-2017-00329 .

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT THIS PATIENT EXPERIENCED ASYMPTOMATIC PARENT VESSEL OCCLUSION (PVO) AFTER PIPELINE EMBOLIZATION PROCEDURE AND IN-STENT STENOSIS. THE STENOSIS WAS GREATER THAN 50% AND WAS FOUND ON ROUTINE FOLLOW UP IMAGING AT 6 MONTHS. THE PVO WAS FOUND DURING ROUTINE FOLLOW UP AT 12 MONTHS. THERE WAS NO NEW PERMANENT NEUROLOGICAL DEFICIT AND THE GOAL OF COMPLETE ANEURYSM OCCLUSION WAS ACHIEVED. THERE WAS LEPTOMENINGEAL COLLATERALIZATION FROM THE IPSILATERAL ANTERIOR AND POSTERIOR CEREBRAL ARTERIES. THIS (B)(6) PATIENT PRESENTED WITH A HEADACHE AND WAS FOUND TO HAVE AN ANEURYSM IN THE RIGHT MCA BIFURCATION MEASURING 14.1MM WITH A NECK WIDTH OF 8.5MM. THE PATIENT WAS TREATED WITH 6 PIPELINE. PRIOR TO THE EMBOLIZATION PROCEDURE THE PATIENT HAD A P2Y12 LEVEL OF 170 PRU AND THEN 206 PRU THE FOLLOWING MORNING. THIS PATIENT WAS GIVEN 150MG CLOPIDOGREL AND THE P2Y12 LEVEL SUBSEQUENTLY DECREASED TO 95 PRM LATER ON POST EMBOLIZATION DAY 1. THE PATIENT WAS DISCHARGED HOME ON A REGIMEN OF ASPIRIN 325MG AND CLOPIDOGREL 75MG DAILY. A P2Y12 LEVEL 1 MONTH LATER WAS 3 PRU, FOR WHICH CLOPIDOGREL WAS DECREASED TO 75 MG EVERY OTHER DAY. A P2Y12 LEVEL AT THE TIME OF THE 6 MONTH FOLLOW UP WAS 206 PRU. AT THE 6 MONTH FOLLOW UP ANGIOGRAPHY THE TREATED ANEURYSM WAS FOUND TO BE OCCLUDED SO CLOPIDOGREL WAS THEN DISCONTINUED AT THAT TIME. AT THE ROUTINE 12 MONTH FOLLOW UP, THE PARENT VESSEL OCCLUSION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231524 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other